NCT05914961

Brief Summary

ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer (TNBC) under immune checkpoint inhibitor (ICI) therapy on pathological complete response (pCR) and event-free survival in early TNBC patients, and objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in advanced or metastatic TNBC.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
108mo left

Started Jun 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jun 2024Apr 2035

First Submitted

Initial submission to the registry

June 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2035

Last Updated

February 12, 2026

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

June 13, 2023

Last Update Submit

February 9, 2026

Conditions

TNBC - Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR)

    Evaluation of CRP kinetics to predict pCR in early (pathologic complete response) TNBC treated with ICI in combination with chemotherapy. The CRP value is determined from blood samples.

    duration of therapy and follow-up data (10 years)

Secondary Outcomes (1)

  • Prognostic value of CRP kinetics under ICI therapy on objective response rate (ORR), progression free survival (PFS), event-free survival (EFS), invasive recurrence free survival and overall survival (OS)

    duration of therapy and follow-up data (10 years)

Study Arms (2)

Control Group

Chemotherapy without immunotherapy

Experimental Group

Chemotherapy in combination with immunotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

225 patients will be included in the study after written informed consent. Of 75 patients in the control group, which will undergo chemotherapy of physician's choice, 50 patients will be diagnosed with early TNBC and 25 patients will be diagnosed with advanced or metastatic TNBC. Of 150 patients in the experimental group, which will undergo chemotherapy in combination with ICIs, 100 patients will be diagnosed with early TNBC and 50 patients will be diagnosed with advanced or metastatic TNBC.

You may qualify if:

  • women ≥ 18 years of age
  • histologically proven early or advanced or metastatic invasive breast cancer irrespective of therapy line
  • ER-negative and progesterone receptor (PR)-negative and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0-2+, Fluorescence In Situ Hybridization (FISH) neg.)
  • patients with advanced or metastatic disease must be programmed cell death ligand 1 (PD-L1)-positive (IC ≥ 1 or combined positive score (CPS) ≥ 10) in the experimental group
  • planned ICI therapy in combination with chemotherapy in the experimental group
  • written informed consent into ICK-breast

You may not qualify if:

  • ER-positive or PR-positive
  • HER2-positive (IHC 2+, FISH pos or IHC 3+)
  • pregnant or lactating patients
  • inadequate general condition (not fit for chemotherapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Women's Health

Tübingen, 72076, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample to assess laboratory parameters: Leukocytes, neutrophil granulocytes, lymphocytes, hemoglobin, hematocrit, thrombocytes, creatinin, glomerular filtration rate (GFR), serum glutamic oxaloacetic transaminase (GOT), serum glutamic pyruvic transaminase (GPT), bilirubin, lactate dehydrogenase (LDH), thyroid stimulating hormone (TSH), fT3 (free triiodothyronine), fT4 (free thyroxine), amylase, CRP, biomarkers related to immune response

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tobias Engler, Dr.

    Department of Women's Health Tübingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Engler, Dr.

CONTACT

07071 29 82211Tobias.Engler@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 22, 2023

Study Start

June 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2035

Last Updated

February 12, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)